COMPANY
PharmaEssentia
FDA-approved therapeutic company Clinical Phase 3
Hiring
| Title | Location (from posting) | Employer posted | First seen |
|---|---|---|---|
| Associate Director Compensation & Benefits | Burlington, MA | Not stated | Oct 22, 2026 |
| Associate Director Business Development & Corporate Strategy | Remote | Not stated | Oct 17, 2026 |
| Manager, Commercialization Analytics and Insights | Burlington, MA | Not stated | Oct 17, 2026 |
| PE-CX & Digital Analytics Lead | Remote | Not stated | Oct 17, 2026 |
| HRIS and Benefits Specialist | BEDFORD, MA | Not stated | Oct 16, 2026 |
Timeline
- FDA FDA New indication / efficacy supplement: BESREMI (ropeginterferon alfa-2b-njft) — BLA761166/13, Aug 28, 2026. Applicant at approval: PharmaEssentia Corporation. source ↗
- Trial start Phase 4: Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera source ↗
- Trial start Phase 3: P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk source ↗
- Trial start I: Phase I Open-Label Study of P1101 Followed by P1801 in Advanced Solid Tumors source ↗
- Trial start I: A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers source ↗
- Trial start —: HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan source ↗
- Trial start Phase 3: A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV source ↗
- Trial start Phase 2: A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET source ↗
- Trial start Phase 1: The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection source ↗
- Trial start Phase 3: A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp source ↗
- Trial start Phase 1: Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects source ↗
- Trial start Phase 2: A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU source ↗
- Trial start Phase 1: The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection source ↗
- Trial start Phase 3: Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance source ↗
- Trial start 3: Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection source ↗
- Trial start 1: KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis source ↗
- Trial start Phase 2: Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection source ↗
- Trial start Phase 1: Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects source ↗
Upcoming milestones
- Nov 18, 2027 (ESTIMATED) · Phase 3 · P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk · NCT06468033
- Dec 31, 2028 (ESTIMATED) · I · Phase I Open-Label Study of P1101 Followed by P1801 in Advanced Solid Tumors · NCT07053904
Clinical trials (lead sponsor) 17
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06468033 | P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk | Phase 3 | Active, not recruiting | Jul 18, 2025 | Nov 18, 2027 (estimated) |
| NCT06290765 | Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera | Phase 4 | Withdrawn | Aug 1, 2026 | Dec 31, 2026 (estimated) |
| NCT06665776 | HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan | Not listed | Terminated | Mar 14, 2023 | May 27, 2026 (actual) |
| NCT04285086 | Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance | Phase 3 | Active, not recruiting | Aug 25, 2020 | Nov 12, 2024 (actual) |
| NCT04638439 | The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection | Phase 1 | Completed | Aug 17, 2022 | Apr 8, 2026 (actual) |
| NCT05482971 | A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET | Phase 2 | Active, not recruiting | Sep 29, 2022 | May 9, 2025 (actual) |
| NCT05481151 | A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV | Phase 3 | Active, not recruiting | Oct 26, 2022 | Jun 30, 2025 (actual) |
| NCT05485948 | A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU | Phase 2 | Active, not recruiting | Oct 8, 2021 | Sep 7, 2022 (actual) |
| NCT07053904 | Phase I Open-Label Study of P1101 Followed by P1801 in Advanced Solid Tumors | I | Enrolling by invitation | Apr 21, 2025 | Dec 31, 2028 (estimated) |
| NCT05522816 | KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis | 1 | Completed | Oct 27, 2015 | Mar 10, 2021 (actual) |
| NCT06698861 | A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers | I | Completed | Aug 19, 2024 | Feb 6, 2025 (actual) |
| NCT05231044 | A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp | Phase 3 | Completed | Dec 21, 2021 | Nov 20, 2023 (actual) |
| NCT04774107 | The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection | Phase 1 | Completed | Nov 26, 2020 | Jul 18, 2022 (actual) |
| NCT05245578 | Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects | Phase 1 | Completed | Nov 16, 2021 | Nov 22, 2021 (actual) |
| NCT04382937 | Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection | 3 | Completed | Jan 12, 2016 | Jul 15, 2020 (actual) |
| NCT05129644 | Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects | Phase 1 | Completed | Nov 7, 2009 | Jun 26, 2010 (actual) |
| NCT01587586 | Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection | Phase 2 | Completed | Oct 18, 2011 | Nov 22, 2016 (actual) |
FDA records (last 2 years)
- FDA New indication / efficacy supplement: BESREMI (ropeginterferon alfa-2b-njft) — BLA761166/13, Aug 28, 2026. Applicant at approval: PharmaEssentia Corporation. source ↗
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